MAUDE Adverse Event Report: ANIKA THERAPEUTICS INC ORTHOVISC; SODIUM HYALURONATE FOR INTRA-ARTICUL

Model Number 630-254

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Burning Sensation (2146)

Event Date 09/23/2014

Event Type  Injury  

Event Description

The surgeon reported that ten minutes after receiving her first injection of orthovisc, the pt experienced chest pains.The pt was taken to the emergency room.The pt reported having a burning sensation in her chest.The surgeon reported the pt had no history of heart disease.

Manufacturer Narrative

The device was not available to be returned and the lot number is unk.No further evaluation or investigation is possible.

• Brand Name: ORTHOVISC
• Type of Device: SODIUM HYALURONATE FOR INTRA-ARTICUL
• Manufacturer (Section D): ANIKA THERAPEUTICS INC; 32 wiggins ave; bedford MA 01730
• Manufacturer Contact: stephanie bunch ; 32 wiggins ave; bedford, MA 01730 ; 7814579256
• MDR Report Key: 4162976
• MDR Text Key: 18544184
• Report Number: 3007093114-2014-00004
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P030019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 630-254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/23/2014
• Initial Date FDA Received: 10/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization